Trastuzumab biosimilar - Biocon/Mylan

Drug Profile

Trastuzumab biosimilar - Biocon/Mylan

Alternative Names: Bmab-200; CANMAb; Hercules; HerMyl 1401O trastuzumab; Hertraz; MYL 1401O

Latest Information Update: 21 Jul 2017

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At a glance

  • Originator Biocon
  • Developer Biocon; Mylan
  • Class Antineoplastics; Monoclonal antibodies
  • Mechanism of Action ERBB 2 receptor antagonists; Immunomodulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Breast cancer

Most Recent Events

  • 29 Sep 2017 FDA assigned Biosimilar User Fee Act (BsUFA) action date postponed to 03/12/2017 for trastuzumab biosimilar for Breast cancer
  • 17 Jul 2017 Biocon completes a phase I trial in Breast cancer (metastatic disease) in India, before July 2017 (CTRI2011-08-001958)
  • 13 Jul 2017 Preregistration for Breast cancer (Metastatic disease) in Australia (IV) before July 2017
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